Locking Proximal Femur Plate System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ORTHOPEDIATRICS® LOCKING PROXIMAL FEMUR PLATE SYSTEM DISTAL FEMORAL OSTEOTOMY SYSTEM EUDAMEDLocking Proximal Femur Plate System FDA UDI
- Generic Name
- Growth-correction orthopaedic fixation plate kit FDA UDI
- Device Name
- ORTHOPEDIATRICS® LOCKING PROXIMAL FEMUR PLATE SYSTEM DISTAL FEMORAL OSTEOTOMY SYSTEM EUDAMED110 Deg x 3.5mm Plate, 12mm Offset, 3 Hole FDA UDI
- Model / Reference
- 00-0907-1243 EUDAMEDFDA UDI00-0907-0102 EUDAMED
- Description
- 110 Deg x 3.5mm Plate, 12mm Offset, 3 Hole FDA UDI
Identifiers
- Catalog Number
- 00-0907-1243 FDA UDI
- Primary DI / UDI-DI
- 00841132104170 EUDAMEDFDA UDI
- Basic UDI-DI
- 08411321LPFR2 EUDAMED
- 510(k) Number
- K111086 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS EUDAMED
- GMDN Term
- Growth-correction orthopaedic fixation plate kit FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Growth-correction orthopaedic fixation plate kit
Locking Proximal Femur Plate System by Orthopediatrics Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Growth-correction orthopaedic fixation plate kit.
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Cleared under the same submission
K111086 also covers:
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Orthopediatrics Corp.
Sources (2)
- FDA UDI 17514171-e537-40f2-b199-ecb351435876 36 fields · synced Oct 7, 2026
- EUDAMED 3928b68e-3d75-4d98-8e63-620b1a4fce26 61 fields · synced Oct 7, 2026